Senior Consultant, Computer Systems
Compliance
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| Position Description: |
|
The
Senior Consultant, Computer Systems Compliance develops and implements
the validation process for DataCeutics' clients.
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| Specific
responsibilities include: |
- Performing all elements of the validation
process
- Developing and implementing validation plans
- Conducting vendor audits and preparing audit
reports
- Performing assessment activities to formulate
validation plans and 21 CFR Part 11 compliance plans
- Executing validation plans and performing project
management activities;
- Developing and writing SOPs
- Developing test scripts and user acceptance tests and
executing test scripts;
- Performing IQ/OQ activities
- Preparing all validation / 21 CFR Part 11 reports,
documents, and deliverables
- Conducting validation and 21 CFR Part 11
training
- Contributing to the development of validation
methodology and 21 CFR Part 11 compliance strategies
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| Requirements: |
- Bachelor's degree in computer science, life science
or related field
- 3 plus years experience developing and implementing
the validation process and validation deliverables
- 3 plus years Pharmaceutical or CRO industry
experience with clinical systems
- Systems or programming background
- Experience with multiple CDM software applications,
e.g., Phase Forward Clintrial, Oracle Clinical, etc. and multiple
platforms, e.g., UNIX, Windows NT, VAX/VMS, etc.; and SAS are
desirable
- Excellent understanding and experience with industry
regulations, standards, and guidelines, e.g., ICH, GCP, validation, 21
CFR Part 11, etc.
- Excellent interpersonal, communication,
organizational, and project management skills
- Excellent presentation and writing skills
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| Who
We Are: |
DataCeutics is the leader in clinical
information technology. We provide information technology support and
services to the pharmaceutical, biotechnology and CRO industry in the
areas of clinical research, clinical data management and biostatistics.
Our company has a strong tradition and reputation in the pharmaceutical
and biotechnology industry. We offer our clients a broad array of
software-related services, software products, and expert
consulting. |
| Compensation And Benefits: |
| This is
a salaried position with an excellent compensation/benefits package and
flexible work arrangements. |
- Health insurance
- Disability insurance
- Dental insurance
- Participation in a 401K retirement plan
- Paid vacation
- Paid holidays
- Paid sick leave
- Bonus
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| Professional Development: |
| As part
of on-going professional development, DataCeutics actively supports
training in current technology, software applications, regulations and
project management practices. |
If you are interested in applying for employment
at DataCeutics,
email:
dciinfo@dataceutics.com |
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